Fluocinolone acetonide implant offers hope for patients with chronic macular edema

October 15, 2006

Durham, NC-A fluocinolone acetonide sustained drug delivery system (Retisert, Bausch & Lomb) implanted in patients with chronic macular edema associated with retinal venous occlusive disease reduced the edema and improved visual acuity in a significant portion of the eyes of 19 patients enrolled in the first 12 months of a 3-year study.

Durham, NC-A fluocinolone acetonide sustained drug delivery system (Retisert, Bausch & Lomb) implanted in patients with chronic macular edema associated with retinal venous occlusive disease reduced the edema and improved visual acuity in a significant portion of the eyes of 19 patients enrolled in the first 12 months of a 3-year study.

About 70% of the eyes remained stable or gained ≥2 lines at 12 months, explained Rajeev S. Ramchandran, MD, a third-year resident at the Duke University Eye Center, Durham, NC. He presented the 1-year data on 17 of 19 patients.

While the fluocinolone acetonide device is a promising treatment capable of reversing chronic macular edema, clinicians should carefully monitor patients' IOP and lens status, he noted. Postoperatively, about 50% of the patients in this study were using IOP-lowering medication, 40% required filtering surgery, and 70% who had been phakic preoperatively required cataract surgery.

Inclusion criteria

In this study, the median duration of vein occlusion, whether central or branch, was about 13 months (range, 6 to 49 months). Prior to being enrolled in this study, the patients had undergone steroid injections or other treatments that either had been unsuccessful or did not completely resolve the macular edema, Dr. Ramchandran said.

Treatment options for retinal vein occlusion include observation, focal laser photocoagulation, arteriovenous sheathotomy, posterior sub-Tenon's triamcinolone acetonide (Kenalog, Westwood-Squibb), intravitreal triamcinolone acetonide, and intravitreal anti-vascular endothelial growth factor (VEGF) therapy.

All but one patient with central retinal vein occlusion in this study had initially received intravitreal injections of triamcinolone acetonide to determine if they would have a response to steroids and whether the response would be extended, said Glenn J. Jaffe, MD, professor of ophthalmology, Duke University Eye Center, senior author of the study.

"Virtually all of the patients who were in the study were given intravitreal steroids and had an initial response, but then the effect of the steroids wore off," Dr. Jaffe said.

"In particular, in those patients who had undergone vitrectomies, the effect of the intravitreal steroid injection wore off especially quickly at the doses given," Dr. Jaffe continued.

Outcome measures

The goal of this study was to test the safety and effectiveness of the fluocinolone acetonide device in patients with retinal venous occlusive disease and to determine if the effects could be sustained. The main outcome measures were central foveal thickness, visual acuity (ETDRS letters), and IOP.

The trial involved 19 eyes of 19 patients, five with branch retinal vein occlusion (BRVO) and 14 with central retinal vein occlusion (CRVO). All had refractory macular edema. Median IOP was <21 mm Hg in all patients preoperatively, and they used 1 IOP-lowering medication.

The median age of patients was 65 (range, 50 to 84). One patient was lost to follow-up at 6 months, and another developed endophthalmitis and subsequently had the implant removed.

Implant insertion

The 0.59-mg device was inserted through a 3.5-mm sclerectomy at the pars plana. Visual acuity, central foveal thickness, determined by optical coherence tomography (OCT), and IOP were recorded during the first 12 months following implantation.

Although patients were classified as having BRVO or CRVO, all data were analyzed together.

Results for visual acuity, the primary study outcome, were favorable. The median preoperative visual acuity was 20/126; it improved to 20/80 at 2 months postoperatively and remained stable through month 12.

Studies have shown that improvement to 20/80 or better improves patients' functionality, enabling them to read, for example, although they still will not be able to drive, Dr. Ramchandran said.

Evaluated by gain or loss in lines of improvement in visual acuity from baseline, most patients also had improvement.

Fourteen of 19 eyes gained 2 or more lines by 2 months postoperatively and a median of 3 lines at 12 months. Four eyes had decreased vision, and one was unchanged.

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